DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species B (Figures 4-8 and 10) in the reply filed on 07/28/2926 is acknowledged.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 9-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (E.P. Application No. 1104327 B1), and further in view of Varol (U.S. Patent No. 12193735 B2).
Regarding independent claims 1 and 10, and claim 11, Ni discloses a radiofrequency ablation system (see Fig. 8), comprising a radiofrequency ablation instrument and a radiofrequency ablation electrode (49) (pa. 0020, 0028 & Fig. 6), which includes an internal circulation structure (combination of circulation means 62 and infusion pump 63) (pa. 0032-0033 & Fig. 8) and an external perfusion structure (combination of cylindrical wall elements forming an inner concentric channel and an outer concentric channel, openings for the outflow of a fluid, and a distal end as seen in the embodiment of Fig. 6);
wherein the internal circulation structure enables a cooling medium (combination of a cooling and wetting medium, pa. 0019) in a liquid supply device (57) to reach a working terminal of the radiofrequency ablation electrode (pa. 0032), so as to cool the working terminal of the radiofrequency ablation electrode and a lesion tissue around the working terminal (pa. 0021), and enables the cooling medium to flow back to the liquid supply device (see Fig. 8); and
the external perfusion structure enables the cooling medium to flow through openings on the working terminal of the radiofrequency ablation electrode to reach the lesion tissue (see Fig. 6).
However, Ni does not disclose the openings are micropores.
Varol, in the same field of endeavor, teaches a system with cooling fluid (2100) comprising an outer tube (2160) and a fluid guide tube (2140) (analogous to the inner concentric channel of Ni), both with one or more apertures (2165, 2145) to allow cooling fluid to flow out of the apertures (Col. 23, lines 56-64; Col. 24, lines 6-14 & Fig. 21). In various examples, each aperture is a hole of diameter between 1 micron and 200 microns (Col. 27, lines 28-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the openings of Ni to have diameters between 1 micron and 200 microns, as taught by Varol, for the purpose of facilitating egress of cooling fluid to the tissue in a manner suitable to the user to reach a desired outcome of the treatment.
Regarding claims 2 and 12, Ni discloses the internal circulation structure comprises an inner needle tubing and an outer needle tubing (see Fig. 6), the outer needle tubing sleeves the inner needle tubing and forms a fluid channel with the inner needle tubing (see Fig. 6), the cooling medium is capable of being introduced into the fluid channel, an inner needle tubing flow channel into which the cooling medium is capable of being introduced is provided in the inner needle tubing (see Fig. 6), a front end of the inner needle tubing flow channel is in communication with a front end of the fluid channel, a rear end of the inner needle tubing flow channel and a rear end of the fluid channel are both (indirectly) connected with the liquid supply device (see Figs 6 and 8); the outer needle tubing is provided with a needle tip at a front end thereof and an insulating layer at a rear end thereof (pa. 0021), and the outer needle tubing is also electrically connected with a radiofrequency head.
Examiner notes that when the radiofrequency ablation electrode is introduced towards a tumor, radiofrequency energy is delivered via “non-insulated part of the electrode” (i.e., the working terminal of the radiofrequency ablation electrode). Therefore, since the working terminal of the radiofrequency ablation electrode is described as being not-insulated, as opposed to just simply “conductive”, it is inferred that a proximal portion of the radiofrequency ablation instrument is insulated to avoid unwanted treatment of non-targeted tissue.
Lastly, Ni discloses the cooling medium is conductive (hypertonic saline solution), and the cooling medium is capable of entering the fluid channel and then overflowing from the openings (pa. 0019).
However, Ni does not disclose the external perfusion structure comprises the micropores, and the micropores are formed in an area of the working terminal of the external needle tubing.
Varol, in the same field of endeavor, teaches a system with cooling fluid (2100) comprising an outer tube (2160) and a fluid guide tube (2140) (analogous to the inner concentric channel/inner needle tubing of Ni), both with one or more apertures (2165, 2145) to allow cooling fluid to flow out of the apertures (Col. 23, lines 56-64; Col. 24, lines 6-14 & Fig. 21). In various examples, each aperture is a hole of diameter between 1 micron and 200 microns (Col. 27, lines 28-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the openings of Ni to have diameters between 1 micron and 200 microns and include them on in an area of the working terminal of the external needle tubing, as taught by Varol, for the purpose of facilitating egress of cooling fluid to the tissue in a manner suitable to the user to reach a desired outcome of the treatment.
Regarding claims 3 and 13, Ni/Varol combination discloses the radiofrequency ablation electrode further comprises a liquid cavity, the liquid cavity is located at the rear end of the outer needle tubing and configured to accommodate the cooling medium (Ni, see Fig. 6), and the liquid cavity is in communication with the fluid channel and the inner needle tubing flow channel (Ni, see Fig. 6); and
the liquid supply device comprises a cooling medium source (58) and a cooling medium recovery device (58), the liquid cavity comprises a water inlet cavity and a backwater cavity (see arrows in the Fig. 6 indicating direction of fluid flow), the water inlet cavity is separated from the backwater cavity (Ni, see Fig. 6); the water inlet cavity is connected with the cooling medium source through a water inlet pipe (Ni, see Fig. 8), the backwater cavity is connected with the cooling medium recovery device through a backwater pipe (Ni, see Fig. 8), the cooling medium source is capable of providing the cooling medium, the cooling medium recovery device is capable of recovering the cooling medium (Ni, pa. 0032); a rear end of the inner needle tubing extends into the water inlet cavity, so that the rear end of the inner needle tubing flow channel is in communication with the water inlet cavity (via a front end of the inner needle tubing flow channel), and the rear end of the fluid channel is in communication with the backwater cavity (via a front end of the fluid channel).
Regarding claims 4 and 14, Ni/Varol combination discloses the water inlet pipe and/or the backwater pipe are further provided with a water-volume adjusting device, the water-volume adjusting device is configured to adjust a water inflow or a backwater volume of the cooling medium, so as to adjust a perfusion volume of the cooling medium (Ni, pa. 0028); wherein the cooling medium is sterile physiological saline or liquid medicine (Ni, pa. 0019), the perfusion volume of the cooling medium is a volume of the cooling medium entering a human body within unit time, and the perfusion volume of the cooling medium is 0.1 ml to 2.0 ml per minute (Ni, see experimental groups ex vivo test on paragraph 0040).
Regarding claims 5 and 15, Ni discloses the invention substantially as claimed in claims 1-2, and 10, 12 and discussed above.
However, Ni does not disclose wherein a pore size of each micropore is 0.005 mm to 0.05 mm.
Varol, in the same field of endeavor, teaches a system with cooling fluid (2100) comprising an outer tube (2160) and a fluid guide tube (2140) (analogous to the inner concentric channel/inner needle tubing of Ni), both with one or more apertures (2165, 2145) to allow cooling fluid to flow out of the apertures (Col. 23, lines 56-64; Col. 24, lines 6-14 & Fig. 21). In various examples, each aperture is a hole of diameter between 1 micron (0.001 mm) and 200 microns (0.2 mm) (Col. 27, lines 28-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the openings of Ni to have diameters between 0.005 mm to 0.05 mm, as taught by Varol, for the purpose of facilitating egress of cooling fluid to the tissue in a manner suitable to the user to reach a desired outcome of the treatment.
Regarding claims 9 and 19, Ni/Varol combination discloses wherein the diameter of the outer needle tubing is at least 1.0 mm (Ni, pa. 0025).
Claim 6-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ni and Varol as applied to claim 1 above, and further in view of Daniel (U.S. Application No. 20200197082 A1).
Regarding claims 6 and 16, Ni/Varol combination discloses an outer wall of the protective tube is flush with an outer edge of the needle tip (Ni, see Fig. 6).
However, they do not discloses wherein the insulating layer is an insulating tube, an outer sleeve also sleeves the front end of the outer needle tubing, the outer sleeve and the insulating tube are sequentially arranged from front to back in an axial direction of the outer needle tubing to form a protective tube; wherein an outer wall of a front end of the outer sleeve is flush with the outer edge of the needle tip, an outer wall of a rear end of the outer sleeve is flush with an outer wall of a front end of the insulating tube; the outer sleeve is configured to release radiofrequency energy, and contrast holes are further formed on the outer sleeve.
Daniel, in the same field of endeavor, teaches a catheter (10) comprising a tip electrode (21) (pa. 0077) (analogous to the needle tip of Ni), a coupling member (81) covered by a nonconducting, biocompatible sheath (84) (i.e., an insulating tube comprising an insulating layer) (pa. 0096 & Fig. 1B). Distal to the sheath is a flex circuit (20) (i.e., an outer sleeve) formed with irrigation apertures (26) (i.e., contrast holes) so irrigation fluid can exit a distal assembly (15) to cool surrounding tissue (pa. 0069, 0079). The flex circuit includes electrically-conducting traces (30) are provided on an outer surface (94) of the flex circuit (pa. 0079), wherein the conductive traces are configured/capable of releasing radio-frequency energy (pa. 0081). As seen in Fig. 1B, the outer sleeve and the insulating tube are sequentially arranged from front to back in an axial direction of the outer needle tubing to form a protective tube, wherein an outer wall of a front end of the outer sleeve is flush with the outer edge of the needle tip, an outer wall of a rear end of the outer sleeve is flush with an outer wall of a front end of the insulating tube.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the flex circuit taught by Daniel, to the outer needle tubing of Ni for the purpose of providing conductive traces capable of passing RF energy along the length of a catheter from a controller to the electrode (Daniel, pa. 0081) and to have added the biocompatible sheath to provide a protective insulative layer that is heat-resistant and whose shape and elasticity are not substantially affected by exposure to the heat (Daniel, pa. 0097).
Regarding claims 7 and 17, Ni/Varol combination discloses wherein a plurality of rings of the micropores are formed on the outer needle tubing in the axial direction (Ni, see Fig. 6).
However, they do not disclose a plurality of rings of the contrast holes are formed on the outer sleeve tube, the micropores and the contrast holes are staggered from front to back in the axial direction of the outer needle tubing; and after flowing out of the micropores, the cooling medium is capable of entering a gap between the outer needle tubing and the outer sleeve tube and flowing out of the contrast holes.
Daniels, in the same field of endeavor, teaches the flex circuit (20) (i.e., the outer sleeve) is formed with a plurality of irrigation apertures (26) (i.e., contrast holes) so irrigation fluid can exit a distal assembly (15) to cool surrounding tissue (pa. 0069, 0079). As seen in Fig. 3, there exists a gap between the outer sleeve and a post (40) (analogous to the outer needle tubing of Ni) defining one or more irrigation fluid chambers/gap (54) therebetween (pa. 0078). A plurality of irrigation apertures (56) (analogous to the micropores of Ni) are formed throughout generally the entirety of the sidewall of the post, in all radial directions about the longitudinal axis (36), so that irrigation fluid entering the proximal opening and passing through the channel (50) can exit the post in any radial direction through the apertures and into the one or more chambers/gap and further out of the irrigation apertures/contrast holes of the flex circuit/outer sleeve (pa. 0078).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the flex circuit, including the contrast holes taught by Daniel, to the outer needle tubing of Ni, while leaving a gap between, for the purpose of providing improved cooling and adjustable irrigation fluid delivery techniques with effective heat transfer to facilitate effective ablation while minimizing fluid load on the patient (Daniel, pa. 0006).
Examiner further notes that the resultant combination would lead to the micropores and the contrast holes being staggered from front to back in the axial direction of the outer needle tubing, while creating a gap between the outer needle tubing and the outer sleeve tube to allow the cooling medium to flow out of the micropores, into the gap, and further flowing out of the contrast holes.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ni and Varol as applied to claim 1 above, and over Daniel as applied to claim 6 above, and in view of Claude (U.S. Application No. 20170143201 A1), in view of Ostroot (U.S. Application No. 20200163709 A1), in view of Jun (U.S. Application No. 20060122593 A1), and further in view of Maytal (U.S. Application No. 20100256620 A1).
Regarding claims 8 and 18, Ni discloses the needle tip is a triangular needle tip with a cutting edge (pa. 0015).
Varol teaches a pore size of each micropore is 0.05 mm to 0.5 mm (Col. 27, lines 28-30).
Daniel teaches the flex circuit (20) (i.e., the outer sleeve) includes the electrically-conducting traces (30) are provided on an outer surface (94) of the flex circuit (pa. 0079), wherein the traces can be made of different metals (pa. 0080). Furthermore, Daniels teaches the biocompatible sheath (84) (i.e., the insulating tube) comprising a flexible polymer plastic material (pa. 0096-0097).
However, they do not teach wherein the outer sleeve is a stainless steel metal tube.
Claude, in the same field of endeavor, teaches a surgical instrument comprising a flex circuit with conductive layers, or traces (15), made from material such as, but not limited to, copper, gold, silver, tin, nickel, steel (pa. 0078).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive material of the electrical traces of the flex circuit/outer sleeve material to be made of stainless steel, as taught by Claude, since both conductive materials are known variants in the art and they would both yield the same predictable results of providing a conductive medium for electrical energy to travel through.
However, Ni/Varol/Daniel/Claude combination does not teach wall thicknesses of the outer sleeve and the insulating tube are both 0.01 mm to 0.1 mm.
Ostroot, in the same field of endeavor, teaches an ablation probe comprising an outer sheath (411) (analogous to the outer sleeve) made of an electrically conductive material such as stainless steel (pa. 0030-0031 & Fig. 4) with a wall thickness of about 0.006 inch (0.15 mm) (pa. 0032). The ablation probe further comprises a proximal insulator (431) (analogous to the insulating tube) that is flushed with the outer surface of the outer sheath in order to provide a uniform outer diameter (pa. 0034).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the wall thicknesses of both the outer sleeve and the insulating tube to be 0.01 mm to 0.1 mm, as taught by Ostroot, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
However, Ni/Varol/Daniel/Claude/Ostroot combination does not teach the needle tip is welded at the front end of the outer needle tubing.
Jun, in the same field of endeavor, teaches a hollow electrode (20) comprising a refrigerant tube (30) and a spearhead tip (10), wherein the tip is incorporated with the hollow electrode via welding (pa. 0029 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of attachment of the needle tip of Ni to be attached using welding techniques, as taught by Jun, since both are known variants in the art and they would both yield the same predictable results of attaching a tip to the rest of the ablation electrode structure.
However, Ni/Varol/Daniel/Claude/Ostroot/Jun combination does not teach a gap between the outer sleeve and the outer needle tubing is 0.01 mm to 0.05 mm.
Maytal, in the same field of endeavor, teaches a flexible cryoprobe operable to cool tissue (pa. 0050 & Fig. 2a), comprising a shaft (102) with an outer tube (106) (analogous to the outer sleeve) having an outer diameter less than 1.5 mm (pa. 0081) and with an inner tube (122) (analogous to the outer needle tubing) having outer diameter less than 1.0 mm (pa. 0082). The shaft further comprises a space between the inner tube and the outer tube which constitutes an annular gas lumen (111) (pa. 0083), wherein the space/gap is less than 0.5 mm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the gap between the outer sleeve and the outer needle tubing to be between 0.01 mm to 0.05 mm, as taught by Maytal, for the purpose of providing efficient cooling to cryoablation temperatures (Maytal, pa. 0089).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Curley (US 20200015880 A1) teaches ablation systems and methods that employ irrigation to regulate the temperature of an ablation element in contact with tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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